AnxietyPhase 4SONRISANCT03324828
Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
A Phase 4 study testing Hydroxyzine and Clowns intervention in people with Anxiety, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in the different APO management groups.Patients will be allocated in one of this four groups: hydroxyzine+clown; hydroxyzine alone, clowns… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Hydroxyzine and Clowns intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2017to 29 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 2 and 16 years old
- Patients with programmed major ambulatory surgery.
- Assessment of anesthetic risk ASA I-II.
- Informed consent signed by their legal authorized representatives.
- No antihistaminic allergies.
- Assent signed by children between 12 and 16 years old.
Who cannot join
- Patients with previous surgeries.
- Anesthetic risk ASA more than II.
- Patients with hypersensitivity to the active substance, to any of the excipients, to cetirizine, to other piperazine derivatives, to aminophylline or etilenamida
- Patients with porphyria
- Patients with known QT prolongation, either congenital or acquired
- Patients with known risk factors for QT prolongation including a pre-existing cardiovascular disease, previous electrolyte imbalances, family history of sudden cardiac death, significant bradycardia and concomitant use of drugs with potential known to produce QT prolongation and / or induce Torsades de Pointes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in the different APO management groups.Patients will be allocated in one of this four groups: hydroxyzine+clown; hydroxyzine alone, clowns alone or nothing
- Conditions
- Anxiety
- Being tested
- Hydroxyzine, Clowns intervention
- Keywords
- anxiety, surgery, clown
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxyzineDrug
Hydroxyzine solution
Clowns interventionOther
Clowns intervention
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyzine+no clowns | Active comparator | Patients will receive hydroxyzine solution and no additional intervention Receives: Drug: Hydroxyzine |
| Hydroxyzine+clowns | Experimental | Patients will receive hydroxyzine solution and clowns intervention Receives: Drug: Hydroxyzine; Other: Clowns intervention |
| Placebo+clowns | Active comparator | Patients will receive placebo solution and clowns intervention Receives: Other: Clowns intervention |
| Placebo+no clowns | No intervention | Patients will receive placebo solution and no additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
m-YPAS
Yale Preoperative Anxiety Scale (mYPAS)
Measured: Anxiety in the operation room (average 60 minutes from the begining of the study)
Secondary outcomes (4)
m-YPAS
Yale Preoperative Anxiety Scale (mYPAS)
Measured: Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study)
Cortisol level (blood)
cortisol blood test
Measured: Just before starting surgery (average 75 minutes from the begining of the study)
Cortisol level (salive)
cortisol blood test
Measured: when the patient arrives at operation room(average 45 minutes from the begining of the study)
Anesthesia induction
Anesthesia induction according to the checklist
Measured: Just before starting surgery (average 75 minutes from the begining of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Nov 2017
- Primary completion29 May 2020
- Study completion29 May 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Aleo Lujan, Hospital San Carlos, Madrid
- Investigators
- Esther Aleo Lujan, MD, Study chair, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324828
- Sponsor's protocol ID
- SONRISA
- Acronym
- SONRISA
- Status last verified
- Aug 2020
- First submitted
- 21 Oct 2017
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aleo E, Picado AL, Abancens BJ, Soto Beauregard C, Tur Salamanca N, Esteban Polonios C, Torrejon MJ, Perrino CG, Rivas A, Arias E, Rodriguez D, Rivas MA, Rojo MLR, Garcia PF, Alarcon JR, San Pedro de Urquiza B. Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial. Biomed Res Int. 2021 Nov 11;2021:7394042. doi: 10.1155/2021/7394042. eCollection 2021.
PubMed 34805403Aleo Lujan E, Lopez-Picado A, Rivas A, Joyanes Abancens B, Rodriguez Rojo ML, Fernandez Garcia P, Soto Beauregard C, Rodriguez Alarcon J, Gonzalez Perrino C, San Pedro de Urquiza B, Arias E, Rodriguez D, Esteban Polonio C, Torrejon MJ. Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial. Trials. 2020 Jan 2;21(1):1. doi: 10.1186/s13063-019-3906-2.
PubMed 31898511
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
- ClinicalTrials.gov ID
- NCT03324828
- Acronym / sponsor ID
- SONRISA / SONRISA
- Conditions
- Anxiety
- Keywords
- anxiety, surgery, clown
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in the different APO management groups.Patients will be allocated in one of this four groups: hydroxyzine+clown; hydroxyzine alone, clowns alone or nothing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hydroxyzine+no clowns | Active comparator | Drug: HydroxyzinePatients will receive hydroxyzine solution and no additional intervention |
| Hydroxyzine+clowns | Experimental | Drug: Hydroxyzine, Other: Clowns interventionPatients will receive hydroxyzine solution and clowns intervention |
| Placebo+clowns | Active comparator | Other: Clowns interventionPatients will receive placebo solution and clowns intervention |
| Placebo+no clowns | No intervention | –Patients will receive placebo solution and no additional intervention |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children between 2 and 16 years old
- Patients with programmed major ambulatory surgery.
- Assessment of anesthetic risk ASA I-II.
- Informed consent signed by their legal authorized representatives.
- No antihistaminic allergies.
Key exclusion criteria (6 listed)
- Patients with previous surgeries.
- Anesthetic risk ASA more than II.
- Patients with hypersensitivity to the active substance, to any of the excipients, to cetirizine, to other piperazine derivatives, to aminophylline or etilenamida
- Patients with porphyria
- Patients with known QT prolongation, either congenital or acquired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxyzineHydroxyzine solution | Drug | Hydroxyzine+clowns, Hydroxyzine+no clowns |
| Clowns interventionClowns intervention | Other | Hydroxyzine+clowns, Placebo+clowns |
Primary outcome
m-YPAS
Time frame: Anxiety in the operation room (average 60 minutes from the begining of the study)
Yale Preoperative Anxiety Scale (mYPAS)
4 secondary outcomes
m-YPAS
Time frame: Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study)
Cortisol level (blood)
Time frame: Just before starting surgery (average 75 minutes from the begining of the study)
Cortisol level (salive)
Time frame: when the patient arrives at operation room(average 45 minutes from the begining of the study)
Anesthesia induction
Time frame: Just before starting surgery (average 75 minutes from the begining of the study)
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 34805403Aleo E, Picado AL, Abancens BJ, Soto Beauregard C, Tur Salamanca N, Esteban Polonios C, Torrejon MJ, Perrino CG, Rivas A, Arias E, Rodriguez D, Rivas MA, Rojo MLR, Garcia PF, Alarcon JR, San Pedro de Urquiza B. Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial. Biomed Res Int. 2021 Nov 11;2021:7394042. doi: 10.1155/2021/7394042. eCollection 2021.
- Derived from this study: PubMed 31898511Aleo Lujan E, Lopez-Picado A, Rivas A, Joyanes Abancens B, Rodriguez Rojo ML, Fernandez Garcia P, Soto Beauregard C, Rodriguez Alarcon J, Gonzalez Perrino C, San Pedro de Urquiza B, Arias E, Rodriguez D, Esteban Polonio C, Torrejon MJ. Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial. Trials. 2020 Jan 2;21(1):1. doi: 10.1186/s13063-019-3906-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Aleo Lujan, MD study chair
Hospital Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxyzine and Clowns intervention in people with Anxiety, run by Hospital San Carlos, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
m-YPAS (time frame: Anxiety in the operation room (average 60 minutes from the begining of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03324828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.